A pilot randomised controlled trial to determine if vitamin D treatment will result in a greater bone mass acquisition in pubertal girls - Influence of vitamin D on bone health in pubertal girls
Phase 1
- Conditions
- Hypovitaminosis D in healthy subjects / Subclinical vitamin D deficiency. Recently there have been many reports of vitamin D deficiency in healthy adolescents worldwide. It is not yet known whether this (if uncorrected) has any long term detrimental effects on bone health. Vitamin D is essential for calcium absorption which is required for bone growth.
- Registration Number
- EUCTR2005-004729-25-GB
- Lead Sponsor
- R & D Directorate,Central Manchester and Manchester Children's University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Healthy post-menarchal adolescent girls aged between 12 to 14 years.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Girls with chronic disease (especially liver or kidney problems) or those taking medication affecting bone health will be excluded from the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether vitamin D supplementation to healthy vitamin D deficient girls results in greater bone mass accumulation when compared with their placebo controlled counterparts .;<br> Secondary Objective: To determine whether vitamin D status during puberty has any relationship with ;<br><br> 1) Muscle strength ;<br> 2)Body stores of Iron;<br> 3)Quantitative ultrasound bone measurements.<br> ;<br> Primary end point(s): 1)Increase in bone mineral density and bone mineral content over the 12 month study period;<br><br> 2)Change in body iron stores following administration of vitaminD/Placebo.<br>
- Secondary Outcome Measures
Name Time Method